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The Effect of Reduced Liver Function on Selatogrel Pharmacokinetics

NCT04406896 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-07-04

No results posted yet for this study

Summary

This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of mild and moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of selatogrel (ACT-246475).

Conditions

  • Healthy Subjects
  • Hepatic Impairment

Interventions

DRUG

Selatogrel

A single subcutaneous injection of 16 mg.

Sponsors & Collaborators

  • Viatris Innovation GmbH

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Viatris Innovation GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-22
Primary Completion
2020-10-23
Completion
2020-10-23

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04406896 on ClinicalTrials.gov